NDA 016367

ICU MEDICAL INC

FDA Drug Application

Application #016367

Documents

• Letter: 2005-09-07
• Label: 2005-09-07
• Label: 2006-10-27
• Letter: 2006-10-31

Application Sponsors

NDA 016367

ICU MEDICAL INC

Marketing Status

• Prescription: 002

Application Products

002

INJECTABLE;INJECTION

50MG/ML

1

DEXTROSE 5% IN PLASTIC CONTAINER

DEXTROSE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1971-02-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1975-05-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1975-05-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1975-10-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1975-09-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1976-04-06	STANDARD
LABELING; Labeling	SUPPL	10	AP	1976-04-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1975-11-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1976-11-08	STANDARD
LABELING; Labeling	SUPPL	13	AP	1976-03-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1976-11-23	STANDARD
LABELING; Labeling	SUPPL	16	AP	1976-10-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1977-04-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1978-02-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1978-03-15	STANDARD
LABELING; Labeling	SUPPL	20	AP	1977-09-09
LABELING; Labeling	SUPPL	21	AP	1977-09-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1977-09-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1977-09-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1978-01-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	1978-07-11	STANDARD
LABELING; Labeling	SUPPL	26	AP	1977-09-28
LABELING; Labeling	SUPPL	27	AP	1977-09-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	1978-02-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	1978-06-05	STANDARD
LABELING; Labeling	SUPPL	32	AP	1978-02-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	33	AP	1978-05-31	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	34	AP	1978-09-13	STANDARD
LABELING; Labeling	SUPPL	35	AP	1978-04-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	36	AP	1978-08-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	37	AP	1978-06-05	STANDARD
LABELING; Labeling	SUPPL	38	AP	1978-06-05
LABELING; Labeling	SUPPL	39	AP	1978-02-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	40	AP	1978-06-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	42	AP	1978-09-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	43	AP	1978-08-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	44	AP	1978-09-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	45	AP	1979-02-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	46	AP	1979-03-27	STANDARD
LABELING; Labeling	SUPPL	47	AP	1979-03-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	48	AP	1978-11-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	49	AP	1978-09-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	50	AP	1979-03-27	STANDARD
LABELING; Labeling	SUPPL	51	AP	1979-03-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	52	AP	1978-01-17	STANDARD
LABELING; Labeling	SUPPL	53	AP	1978-01-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	54	AP	1979-02-16	STANDARD
LABELING; Labeling	SUPPL	55	AP	1978-10-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	56	AP	1978-11-01	STANDARD
S; Supplement	SUPPL	57	AP	1979-02-01	STANDARD
LABELING; Labeling	SUPPL	58	AP	1979-07-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	59	AP	1979-12-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	60	AP	1979-11-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	61	AP	1979-12-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	62	AP	1980-04-16	STANDARD
LABELING; Labeling	SUPPL	63	AP	1980-04-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	64	AP	1980-01-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	65	AP	1980-07-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	66	AP	1979-11-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	67	AP	1979-10-10	STANDARD
LABELING; Labeling	SUPPL	68	AP	1980-04-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	69	AP	1981-07-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	71	AP	1980-09-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	72	AP	1981-01-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	73	AP	1981-03-02	STANDARD
LABELING; Labeling	SUPPL	74	AP	1981-03-02
LABELING; Labeling	SUPPL	75	AP	1982-07-08
LABELING; Labeling	SUPPL	76	AP	1981-03-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	77	AP	1981-07-31	STANDARD
LABELING; Labeling	SUPPL	78	AP	1981-07-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	79	AP	1981-09-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	80	AP	1981-10-21	STANDARD
LABELING; Labeling	SUPPL	81	AP	1981-10-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	82	AP	1981-10-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	83	AP	1982-06-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	84	AP	1982-01-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	85	AP	1982-02-01	STANDARD
LABELING; Labeling	SUPPL	86	AP	1982-02-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	87	AP	1982-07-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	88	AP	1983-02-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	89	AP	1984-03-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	90	AP	1982-07-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	91	AP	1984-10-10	STANDARD
LABELING; Labeling	SUPPL	92	AP	1984-10-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	93	AP	1983-01-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	94	AP	1983-06-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	95	AP	1984-02-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	96	AP	1983-09-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	97	AP	1983-12-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	98	AP	1983-01-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	99	AP	1983-08-31	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	100	AP	1984-03-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	101	AP	1984-10-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	102	AP	1984-09-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	103	AP	1984-06-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	104	AP	1984-04-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	105	AP	1985-01-08	STANDARD
LABELING; Labeling	SUPPL	106	AP	1985-01-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	107	AP	1988-08-31	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	108	AP	1984-11-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	109	AP	1985-10-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	110	AP	1985-11-29	STANDARD
LABELING; Labeling	SUPPL	111	AP	1985-11-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	115	AP	1985-09-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	116	AP	1984-10-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	119	AP	1985-01-18	STANDARD
LABELING; Labeling	SUPPL	120	AP	1985-01-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	121	AP	1985-10-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	122	AP	1985-05-03	STANDARD
LABELING; Labeling	SUPPL	125	AP	1985-10-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	130	AP	1985-08-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	132	AP	1985-09-30	STANDARD
LABELING; Labeling	SUPPL	133	AP	1985-11-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	134	AP	1985-06-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	135	AP	1985-06-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	138	AP	1986-01-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	139	AP	1986-02-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	140	AP	1986-08-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	141	AP	1986-11-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	142	AP	1987-07-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	145	AP	1988-10-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	146	AP	1988-08-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	147	AP	1989-06-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	148	AP	1990-02-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	149	AP	1990-01-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	151	AP	1991-09-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	152	AP	1992-01-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	153	AP	1991-08-30	STANDARD
LABELING; Labeling	SUPPL	156	AP	1994-05-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	157	AP	1995-08-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	159	AP	1996-08-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	160	AP	1996-08-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	161	AP	1995-08-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	162	AP	1996-03-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	163	AP	1996-08-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	164	AP	1997-03-28	STANDARD
LABELING; Labeling	SUPPL	165	AP	1997-08-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	166	AP	1997-06-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	167	AP	1997-08-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	168	AP	1998-10-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	169	AP	1999-06-04	STANDARD
LABELING; Labeling	SUPPL	170	AP	2000-03-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	171	AP	2000-03-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	172	AP	2002-04-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	173	AP	2002-04-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	174	AP	2002-11-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	178	AP	2005-09-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	182	AP	2006-10-26	N/A
MANUF (CMC); Manufacturing (CMC)	SUPPL	218	AP	2013-09-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	220	AP	2016-02-23	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	15	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	22	Null	0
SUPPL	23	Null	0
SUPPL	24	Null	0
SUPPL	25	Null	0
SUPPL	28	Null	0
SUPPL	31	Null	0
SUPPL	33	Null	0
SUPPL	34	Null	0
SUPPL	36	Null	0
SUPPL	37	Null	0
SUPPL	40	Null	0
SUPPL	42	Null	0
SUPPL	43	Null	0
SUPPL	44	Null	0
SUPPL	45	Null	0
SUPPL	46	Null	0
SUPPL	48	Null	0
SUPPL	49	Null	0
SUPPL	50	Null	0
SUPPL	52	Null	0
SUPPL	54	Null	0
SUPPL	56	Null	0
SUPPL	57	Null	0
SUPPL	59	Null	0
SUPPL	60	Null	0
SUPPL	61	Null	0
SUPPL	62	Null	0
SUPPL	64	Null	0
SUPPL	65	Null	0
SUPPL	66	Null	0
SUPPL	67	Null	0
SUPPL	69	Null	0
SUPPL	71	Null	0
SUPPL	72	Null	0
SUPPL	73	Null	0
SUPPL	77	Null	0
SUPPL	79	Null	0
SUPPL	80	Null	0
SUPPL	82	Null	0
SUPPL	83	Null	0
SUPPL	84	Null	0
SUPPL	85	Null	0
SUPPL	87	Null	0
SUPPL	88	Null	0
SUPPL	89	Null	0
SUPPL	90	Null	0
SUPPL	91	Null	0
SUPPL	93	Null	0
SUPPL	94	Null	0
SUPPL	95	Null	0
SUPPL	96	Null	0
SUPPL	97	Null	0
SUPPL	98	Null	0
SUPPL	99	Null	0
SUPPL	100	Null	0
SUPPL	101	Null	0
SUPPL	102	Null	0
SUPPL	103	Null	0
SUPPL	104	Null	0
SUPPL	105	Null	0
SUPPL	107	Null	0
SUPPL	108	Null	0
SUPPL	109	Null	0
SUPPL	110	Null	0
SUPPL	115	Null	0
SUPPL	116	Null	0
SUPPL	119	Null	0
SUPPL	121	Null	0
SUPPL	122	Null	0
SUPPL	130	Null	0
SUPPL	132	Null	0
SUPPL	134	Null	0
SUPPL	135	Null	0
SUPPL	138	Null	0
SUPPL	139	Null	0
SUPPL	140	Null	0
SUPPL	141	Null	0
SUPPL	142	Null	0
SUPPL	145	Null	0
SUPPL	146	Null	0
SUPPL	147	Null	0
SUPPL	148	Null	0
SUPPL	149	Null	0
SUPPL	151	Null	0
SUPPL	152	Null	0
SUPPL	153	Null	0
SUPPL	157	Null	0
SUPPL	159	Null	0
SUPPL	160	Null	0
SUPPL	161	Null	0
SUPPL	162	Null	0
SUPPL	163	Null	0
SUPPL	164	Null	0
SUPPL	166	Null	0
SUPPL	167	Null	0
SUPPL	168	Null	0
SUPPL	169	Null	0
SUPPL	171	Null	0
SUPPL	172	Null	0
SUPPL	173	Null	0
SUPPL	174	Null	0
SUPPL	178	Null	0
SUPPL	218	Null	0
SUPPL	220	Null	0

TE Codes

002

Prescription

AP

CDER Filings

ICU MEDICAL INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 16367
            [companyName] => ICU MEDICAL INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DEXTROSE 5% IN PLASTIC CONTAINER","activeIngredients":"DEXTROSE","strength":"50MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"10\/26\/2006","submission":"SUPPL-182","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/016367s182lbl.pdf\"}]","notes":""},{"actionDate":"09\/02\/2005","submission":"SUPPL-178","supplementCategories":"Manufacturing (CMC)-Packaging","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/016367s178lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"DEXTROSE 5% IN PLASTIC CONTAINER","submission":"DEXTROSE","actionType":"50MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2006-10-26
        )

)